The FTC recently challenged scores of pharmaceutical patents as improperly listed in the Orange Book. This was an important because, among the many ways that BigPharma has been accused of abusing the patent system to block lower-cost generic formulations, attacking Orange Book listings has had limited success in the past. In 2020, the First Circuit endorsed antitrust allegations against Sanofi for improperly listed patents. More recently, the Federal Circuit issued a precedential decision limiting the scope of patents that can be permissibly listed in the Orange Book. This is also an important decision because it is one of the few precedential decisions from the Federal Circuit to address this issue. What are the policy implications of the Federal Circuit’s recent ruling regarding Orange Book patent listings?
Read MoreIn Amarin’s pending Hatch-Waxman Vascepa case against Dr. Reddy’s and Hikma, we see at least obstacles to settlement at this time before resolution of the appeal: money, entry and invalidity.
Read MoreThe day after the midterms, Trump fired AG Sessions and tapped Mr. Sessions’ chief-of-staff, Matthew G. Whitaker, to serve in the role as acting Attorney General. Shortly thereafter, the press started to report that Mr. Whitaker was previously an advisory board member for a company known as, World Patent Marketing, before it closed shop following a consent decree with the FTC. It is worth taking a moment to highlight the need for increased IP literacy.
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